GlipiZIDE XL

GlipiZIDE XL can be taken by itself or with other medicines, along with diet and exercise, to help control blood sugar levels in adults with type 2 diabetes mellitus (it is not for type 1 diabetes).

GlipiZIDE XL may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using it exactly as directed on the label or as prescribed by your doctor.

Take GlipiZIDE XL 30 minutes before a meal.

Take the GlipiZIDE XL extended-release tablet once a day with breakfast or your first meal of the day.

Swallow the extended-release tablet whole and do not crush, break, chew, or dissolve it.

Your blood sugar will need to be checked regularly, and you may need other medical tests.

Part of the extended-release tablet shell may appear in your stool, but this will not make the medicine less effective.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store tightly closed at room temperature in the original container away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

You should not use GlipiZIDE XL if you are allergic to GlipiZIDE XL or any of its ingredients or if you have:

• type 1 diabetes;
• a condition called diabetic ketoacidosis; or
• an allergy to sulfa drugs.

Tell your doctor if you have or have ever had:

• diabetic ketoacidosis;
• a blockage in your stomach or intestines caused by disease or surgery;
• severe or ongoing diarrhea;
• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD); or
• liver or kidney disease.

GlipiZIDE XL may increase your risk of heart problems. Ask your doctor about this risk.

It is not known if GlipiZIDE XL will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Follow your doctor's instructions about using this medicine if you are pregnant.

Having high blood sugar during pregnancy may cause complications or medical problems in both mother and baby. Controlling diabetes is very important during pregnancy, and you may need to stop taking GlipiZIDE XL for a short time just before your due date.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Call your doctor right away or seek emergency medical attention if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of low or severely low blood sugar--headache, hunger, sweating, confusion, irritability, dizziness, fast heart rate, feeling jittery, extreme weakness, nausea, tremors, trouble speaking, or seizure; or
• signs of hemolytic anemia--pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Common side effects of GlipiZIDE XL may include:

• diarrhea, nausea, gas;
• dizziness, drowsiness;
• headache, tremors, feeling nervous; or
• skin rash, redness, or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take your dose as soon as you can, but only if you are about to eat a meal. If you miss a meal, skip the missed dose and wait until your next meal. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or doing anything dangerous until you know how GlipiZIDE XL will affect you. Your reactions could be impaired.

When you begin or stop taking GlipiZIDE XL, your doctor may need to change the doses of other medicines you take regularly.

Take your GlipiZIDE XL dose 4 hours before you take colesevelam.

Inform your doctor about all your other medicines, especially miconazole or fluconazole.

Many other drugs can influence your blood sugar and may also impact GlipiZIDE XL. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are mentioned here.